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SMR Shoulder

FDA UDI

Class I (US FDA UDI)

by Limacorporate

Identity

Trade Name
SMR Shoulder FDA UDI
Generic Name
Surgical instrument handle, non-torque-limiting FDA UDI
Device Name
T-Handle with AO connection FDA UDI
Model / Reference
9095.11.202 FDA UDI
Description
T-Handle with AO connection FDA UDI

Identifiers

Catalog Number
9095.11.202 FDA UDI
Primary DI / UDI-DI
08033390099745 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical instrument handle, non-torque-limiting FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument handle, non-torque-limiting

The SMR Shoulder is a high-performance, non-torque-limiting surgical instrument designed for manual manipulation of instruments in orthopedic procedures. Made from metal and/or synthetic materials, this reusable device features a handle with a straight or T-shaped grip, allowing for precise control during operations.

Similar devices

Also classified as Surgical instrument handle, non-torque-limiting.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI b6f01d68-4cbc-4bf1-bd68-5ac7049d0c9c 34 fields · synced Jul 22, 2026